Retrospective Case Review Study Utilized AI-enriched Data

Manassas, Virginia--(Newsfile Corp. - April 22, 2025) - Digital healthcare provider, Notal Vision, announced that the results of a new study evaluating the impact of home OCT data on disease management decisions for neovascular age-related macular degeneration (nAMD) patients were published in the Journal of VitreoRetinal Diseases. While several studies have shown feasibility of home OCT monitoring with nAMD patients acquiring near daily scans, this is the first-ever study to demonstrate changes in physician decision making due to availability of home OCT data.

Fifteen board-certified retina specialists, with diverse practice experiences, were asked to make management decisions after reviewing home OCT data previously collected from patients managed under standard of care treatment by different physicians. The reviewers had access to home OCT volume scans as well as AI-based analytics of hypo-reflective spaces shown on B-scans, en-face projection maps, and longitudinal volume trajectories via a web-based portal. The study demonstrated the strong impact of home OCT data review on physician decision making.

In nearly every case in this simulated environment, physicians made a different decision regarding choice and timing of treatment. In over 42% of cases, physicians decided they would not treat the patient when they were treated in real life. In the remaining cases, when physicians did decide to treat, they would have brought the patients in earlier by one or more weeks in 61% of instances. The study demonstrated that the utilization of home OCT can lead to significant optimization of patient care. The authors concluded a savings potential of over $1 billion to the healthcare system by avoiding early treatments.

The illustration describes data presented to physicians related to Home OCT. Information about the past treatment was provided. The physicians had to make the decision on if and when to plan patient's treatment based on home OCT. The information related to the actual treatment during the shown period was masked.

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"Given the AI-enriched insights in disease activity and treatment response home OCT provides, we all expected it to impact our management, but we were certainly surprised by the level of change in treatment decisions observed in this study," said Ankoor R. Shah, MD, Retina Consultants of Texas, and the senior author of the study. "There is no doubt that review of highly granular, up-to daily OCT data is meaningful and critical to improve personalized care, preventing both over and under treatment."

The projected socio-economic impact of home OCT monitoring was analyzed based on physician decisions made in this study. The first findings were presented by Miguel Busquets, MD of Retina Associates of Kentucky and EyeCare Partners, at the American Society of Retina Specialists annual meeting in Stockholm last year. Further study results were presented by Aleksandra Rachitskaya, MD of Cole Eye Institute at the 2024 EURETINA annual meeting in Barcelona, Spain, and by Paul Hahn, MD of New Jersey Retina and Prism Vision Group at the 2024 American Academy of Ophthalmology annual meeting in Chicago.

Disclaimer: Although the studies are scientifically sound and clinically relevant, they present some limitations, including that it was retrospective in nature and not designed to detect differences in visual outcomes or treatment-related costs. The current study was biased towards earlier treatment compared to actual care because it was not possible for the data reviewing physician to delay care beyond the date of actual treatment. Physician decisions were made based on anatomical data obtained from home OCT alone and visual acuity changes over time were not provided. The relatively small number of physicians, patients and eyes in this study limits the generalizability of the findings to all nAMD patients in the United States. We encourage physicians to read these studies to understand the strengths and limitations of the data. Please note that the FDA has not reviewed these studies. For some claims, Notal Vision may seek to broaden the indications with the FDA in the future using data, such as these studies, to provide the required substantiation. See product labeling [https://notalvision.com/services/scanly-oct] for the indications for use and important safety information.

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About Notal Vision

Notal Vision is a patient-centric ophthalmic remote monitoring services provider extending retinal disease monitoring from the clinic to the home, providing physicians with remote monitoring services to support their patient care between office visits. With a proven approach to home-based, self-operated diagnostics, AI-enabled data analysis, and patient engagement, our goal is to help doctors preserve patients' vision. www.notalvision.com.

The Notal Vision Monitoring Center (NVMC) is a remote, Medicare credentialed ophthalmic monitoring center and the epicenter of patient engagement. Led by practicing ophthalmologists and supported by certified ophthalmic professionals, the Monitoring Center offers a nationwide age-related macular degeneration (AMD) home monitoring service for patients.

The ForeseeHome® AMD Monitoring Program is a comprehensive program, which includes an FDA-cleared device that monitors visual changes in intermediate dry AMD patients at risk of vision loss from undiagnosed wet AMD.

With the addition of the SCANLY Home OCT system to the Notal Vision family of monitoring products, wet AMD patients are able to perform technician-free OCT scanning at home with rapid and self-guided fixation - critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal Vision Monitoring Center provides patient data to the physician via the online SCANLY Portal. Physicians are provided 24/7 access to all their patients' B-scan images from each SCANLY Home OCT scan with the location of the hypo-reflective spaces annotated on each B-scan. The Notal OCT Analyzer (NOA), a proprietary machine learning algorithm, performs automated analysis of the Home OCT scans and generates a report to the physician when a physician specified change is detected. Following physician receipt of a change notification, a patient may be brought to the office for further evaluation if warranted.

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